Duns Number:883094039
Device Description: Tissue Marker System - Stereotactic Delivery
Catalog Number
040201
Brand Name
ImarC™
Version/Model Number
040201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2017
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDW
Product Code Name
Staple, Implantable
Public Device Record Key
90e26d22-733d-48b4-9ad5-bc8408fddd23
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 14, 2015
Package DI Number
10858015005490
Quantity per Package
10
Contains DI Package
00858015005493
Package Discontinue Date
December 07, 2017
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |
| 3 | A medical device with high risk that requires premarket approval | 2 |